Kornimate/medical-research-clean huggingface dataset:
a study to assess the effects of mk0822 in prolonging time to first bone metastasis in men with castration-resistant prostate cancer (0822-030)

Conditions: Prostate Cancer

Summary: the purpose of this study is to investigate the effects of mk0822 in prolonging the time to first bone metastasis in men with castration-resistant prostate cancer.

merck duration of treatment : odanacatib; approximately 36 months (even driven study) - comparator duration of treatment : placebo (unspecified); approximately 36 months (event driven study)

Eligibility criteria:
inclusion criteria: * castration-resistant prostate cancer; increased risk for prostate cancer progression * patient underwent bilateral orchiectomy 6 months or more (i.e., =180 days) prior to visit 1, or is receiving androgen-deprivation therapy and is on a stable regimen for at least 3 months (i.e., =90 days) prior to visit 1. androgen-deprivation therapy may include gonadotropin-releasing hormone agonists such as leuprolide, goserelin, or triptorelin exclusion criteria: * bone metastases or history of bone metastases * patient has other distant metastases (e.g., visceral, including brain, or soft-tissue). patients with regional lymph nodal metastases are eligible * patient has any of the following: 1. currently is receiving a bisphosphonate or other drug therapy for osteoporosis 2. has been treated with an oral bisphosphonate for osteoporosis for more than 3 months within the 2 years prior to visit 1, or for a total of more than 6 months at any time prior to visit 1 3. has been treated with an intravenous bisphosphonate within the 12 months prior to visit 1 * patient has received chemotherapy within the 2 years prior to visit 1 (for example, doxorubicin, cytoxan, estramustine, paclitaxel, docetaxel, etoposide, vinblastine, 5-fluorouracil, interferon, mitoxantrone). this exclusion criterion does not include androgen-deprivation therapy (e.g., gonadotropin-releasing hormone agonists such as leuprolide, goserelin, or triptorelin) * patient has a history of any malignancy other than prostate cancer \<5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer. melanoma, leukemia, lymphoma, and myeloproliferative disorders of any duration are excluded * patient is currently participating in, or has participated in a study with an investigational compound or device within 30 days of signing the informed consent * patient is currently participating in or has at any time in the past participated in a prostate cancer study with a registered medication (i.e., approved by the regulatory agency in which he resides) being tested for the treatment of prostate cancer (an unapproved indication) * patient is currently using a systemically administered azole antifungal (for example, ketoconazole, fluconazole, itraconazole, miconazole, posaconazole, ravuconazole, and voriconazole). patients taking these medications must discontinue their use at least one week prior to starting blinded study medication
effects of exercise training on blood pressure variability

Conditions: Hypertension; Cardiac Disease

Summary: a randomized clinical evaluation of the effects of 2 exercise training modalities on blood pressure variability. recruited subjects will be randomized in two interventional arms: 1) aerobic exercise; 2) combined exercise (aerobic+resistance training).

this study will be a randomized trial, with two intervention arms: 1) aerobic training (at) and 2) combined training (ct) groups. the planned training period will be 12 weeks for each group. patients of both groups will be asked to exercise three times a week. each session will last 80 minutes for each group. population: we will includ 60 male subjects ≥ 45 years old, with established diagnosis of hypertension (of at least one year), treated with pharmacological therapy and with resting bp values under acceptable control (systolic bp \<150 mmhg; diastolic bp \< 90 mmhg) at admission. all groups of anti-hypertensive drugs will be admitted; there will be no restriction on the number of anti-hypertensive drugs taken by the patients. sustained bp increase during the exercise protocol will be managed with the administration of furosemide (25-50 mg/daily). patients who will need further pharmacological interventions for lowering bp will be withdrawn from the study. the following exclusion criteria will be adopted: secondary hypertension; significant heart valve diseases; signs and or symptoms of myocardial ischemia during ergometric test; neurological and or orthopedic conditions contraindicating or limiting et; significant copd (fev1 \<50%), or symptomatic peripheral arterial occlusive disease. patients will be randomly assigned on 1:1 basis to either at or ct group. the randomization code will be developed with a computer random-number generator to select random permuted blocks. exercise training protocols: at group: every exercise session will include 10 min of warm-up, cool-down and flexibility exercises and 60 min of aerobic exercise with cycling and treadmill at 60-70% of vo2 peak. ct group: patients will perform aerobic and resistance exercises in the same session. in order to balance the total amount of exercise, exercise sessions of the ct group will be organized as follow: 40 minutes of aerobic training with cycling and treadmill at 60-70% of vo2 peak; 20 minutes of resistance training including the following exercises: leg press and extension, shoulder press, chest press, low row and vertical traction. all the subjects each strength exercise will be performed by patients at 60% of their maximal voluntary contraction. patients of ct group will performed also 10 min of warm-up, cool-down and flexibility exercises. the one maximum repetition test (1rm) will be used to determine the re load.

Eligibility criteria:
inclusion criteria: * ability to understand the study protocol instructions * ability to sign the informed consent exclusion criteria: * sever cardio-vascular condition * cognitive deficit

Keywords: hypertension cardiac disease excercise
magnesium after alcohol withdrawal treatment

Conditions: Alcohol-Induced Disorders

Summary: the primary purpose is to see if magnesium tablet supplementation will decrease elevated ggt enzyme activity in alcoholic patients immediately after they had been treated for alcohol withdrawal. the secondary aims are to find out whether supplementation decreases the activity of asat and alat enzymes, increases muscle strength, decreases blood pressure and decreases depressive symptoms among these patients.

magnesium (mg) deficiency is common among alcoholics. animal studies have shown that magnesium deficiency aggravates the hepatic damage caused by alcohol. one study on chronic alcoholics suggested that magnesium supplementation over six weeks decreases abnormally high activities of three enzymes related to liver function: serum gamma-glutamyltransferase (ggt), aspartate-aminotransferase (asat) and alanine-aminotransferase (alat), and increases muscle strength \[4\]. these results were, however, significant at the 5% level only when a 1-sided test was applied. it seems that magnesium supplementation may improve liver recovery after a drinking bout, but the evidence is not yet strong enough to warrant clear recommendations for clinical practice. magnesium deficiency may also be one of the symptoms of depression and may aggravate hypertension. the primary purpose of the present randomized, parallel group, double blind trial is to see if oral magnesium supplementation will decrease elevated ggt enzyme activity in alcoholic patients immediately after they had been treated for alcohol withdrawal. the secondary aims are to find out whether supplementation decreases the activity of asat and alat enzymes, increases muscle strength, decreases blood pressure and decreases depressive symptoms among these patients.

Eligibility criteria:
inclusion criteria: * admission to treatment because of an acute alcohol withdrawal * elevated serum ggt (men\>80, women \>50) * age 20-64 years * fixed address and a telephone to facilitate follow-up exclusion criteria: * mg supplementation within the past two months ten 250 mg tablets or more * history of heart rhythm disturbances * contraindications against mg treatment * abnormally high serum creatinine
hmb supplementation in addition to multicomponent exercise in old adults

Conditions: Aging; Frail Elderly Syndrome; Physical Activity

Summary: evidence supports the fact that multicomponent exercise and β-hydroxy-β-methylbutyrate (hmb) supplementation are, separately, effective in improving old adult's health and palliate functional metabolic diseases in the elderly. however, the true effect of hmb supplementation combined with a tailored exercise program in frail old adults is still unknown. thus, the aim of the heal study is to assess the effects of the combination of a daily multicomponent exercise and resistance training intervention in addition to hmb supplementation on old adults' health.

evidence supports the fact that multicomponent exercise and β-hydroxy-β-methylbutyrate (hmb) supplementation are, separately, effective in improving old adult's health and palliate functional metabolic diseases in the elderly. however, the true effect of hmb supplementation combined with a tailored exercise program in frail old adults is still unknown. thus, the aim of the heal study is to assess the effects of the combination of a daily multicomponent exercise and resistance training intervention in addition to hmb supplementation on old adults' health. the findings of the heal study will help professionals from public health systems to identify cost-effectiveness and innovative actions to improve older people's health and quality of life, and endorse exercise practice in older adults living in nursing homes.

Eligibility criteria:
inclusion criteria: * men and women aged ≥70 years living in a nursing home * be able to follow an active physical rehabilitation program * be able to read and wright * voluntary participation * capable and willing to provide an informed consent exclusion criteria: * acute heart attack (recent 3-6 months) or unstable angina * uncontrolled atrial or ventricular arrhythmias * aortic dissecting aneurysm * severe aortic stenosis * acute endocarditis / pericarditis * uncontrolled high blood pressure (\>180/100 mmhg) * acute thromboembolism * acute or severe heart failure * acute or severe respiratory failure * uncontrolled postural hypotension * uncontrolled acute decompensated diabetes mellitus or low blood sugar * a recent fracture in the last month. * coincident participation in any intervention trial * hmb contraindication, intolerance, or allergy * community-dwelling people * have regularly performed exercise (\>20 minutes \>3 days/week) in the last 3 months * malignant diseases (exceptions: basal or squamous-cell skin carcinoma or carcinoma in situ of the uterine cervix) * revascularization within 1 year * severe loss of vision, hearing, or communicative ability * conditions preventing cooperation
colorectal cancer screening with improved shared decision making

Conditions: Colorectal Cancer Screening; Shared Decision Making

Summary: the purpose of this study is to increase colorectal cancer screening by implementing a community-wide shared decision-making (sdm) intervention, which embeds shared decision making within clinical practice and also uses an extensive community engagement campaign. the investigators hypothesize that colorectal cancer screening adherence will be higher in the intervention group (participating communities) compared to the usual care control group (non-participating comparison communities).

clinical practice: all patients 50-75 years seen in the participating primary care clinics during the study period who are non-adherent to crcs recommendation. this sample is anticipated to be n\~50,000 patients. community engagement: includes mailed questionnaires to age-eligible adults residing in intervention and comparison (control) communities (n=2150).

Eligibility criteria:
inclusion criteria: * 50 to 75 years of age * lives in or receives care in the selected intervention or comparison (control) communities * average-risk for colorectal cancer * non-adherent to crcs recommendation * english-speaking * people who consent to participate exclusion criteria: * \ 75 years of age * not living in or receiving care in the selected intervention or comparison communities * high-risk for colorectal cancer * adherent to crcs recommendation * non-english speaking * people who do not consent to participate

Keywords: shared decision making ambulatory care patient-centered care community-wide intervention intervention study longitudinal studies
artesunate plus amodiaquine in malaria in cote d'ivoire

Conditions: Malaria

Summary: the primary objective of this study is to demonstrate the non-inferiority of polymerase chain reaction (pcr)-adjusted adequate clinical and parasitological response to artesunate plus amodiaquine at day 28 in two groups of patients treated at the beginning of an artesunate plus amodiaquine implementation program and 24 months later. the secondary objectives are clinical and biological tolerability evolution of gametocyte carriage proportion of patients without fever at day 3 proportion of patients without parasite at day 3 treatment compliance impact of implementation on anemia measure of parasite sensibility to amodiaquine


Eligibility criteria:
inclusion criteria: * body weight \>=5kg * plasmodium falciparum infection with parasite density \> 2000/µl * fever or history of fever * able to be treated by oral route * no signs of severe malaria * no known allergy to study drugs * no other severe illnesses or underlying diseases * no known pregnancy or negative urinary pregnancy test for women of child bearing age * no participation in another ongoing clinical study the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
comparing the pharmacokinetic profile of ly01612 and caelyx® in chinese subjects with advanced breast cancer

Conditions: Advanced Breast Cancer

Summary: a multicenter, randomized, open-lable, single-dose, two-cycle, double-cross bioequivalence study comparing the pharmacokinetic profile of ly01612 (doxorubicin hydrochloride liposome injection) and caelyx® in chinese subjects with advanced breast cancer


Eligibility criteria:
inclusion criteria: 1. voluntary agreement to provide written informed consent; 2. patients aged ≥18 years and ≤75 years with locally advanced or metastatic breast cancer diagnosed by histology or cytology，and who may benefit from monotherapy of doxorubicin liposomes; 3. life expectancy of at least 3 months; eastern cooperative oncology group (ecog) performance status (ps)\<2; 4. adequate bone marrow function \[leukocyte ≥3,000/mm3, absolute neutrophil count (anc) ≥1,500/mm3, hemoglobin ≥90g/l, and platelet count ≥90,000/mm3； 5. adequate renal function (serum creatinine ≤1.5×institutional upper limit of normal (uln)); 6. adequate coagulation function \[prothrombin time (pt), activated partial thromboplastin time (aptt) ≤1.5×uln\]; 7. adequate hepatic function \[aspartate aminotransferase (ast), alanine aminotransferase (alt) level ≤ 2.5×uln (or ≤5×uln for subjects with liver metastases), and total bilirubin level ≤ 1.5×uln (or ≤ 3×uln for subjects with liver metastases). exclusion criteria: 1. patients with a diagnosis of severe cardiovascular, lung, liver, kidney, gastrointestinal, endocrine, immune system, skin, musculoskeletal, neurological or psychiatric conditions that the researchers did not consider appropriate for inclusion; 2. with a history of myocardial infarction, unstable angina pectoris, coronary revascularization, new york heart association (nyha) grade ≥ⅱ cardiac insufficiency, severe pericardial disease, and severe unstable ventricular arrhythmia, cerebrovascular accident or transient cerebral ischemia or pulmonary embolism within 6 months before randomization; 3. unstable brain metastases; 4. electrocardiogram (ecg) qtc \>480ms; left ventricular ejection fraction \<50% or below the lower limit of study center value; 5. the total cumulative dose of doxorubicin was ﹥350mg/m2 before screening； 6. persistent or active infection requiring systemic treatment; 7. pregnancy or breast feeding; 8. other situations that investigators consider as contra-indication for this study.
stool transplantation to reduce antibiotic resistance transmission

Conditions: Blood Disorders

Summary: during this prospective observational study, the investigators collect the information about the outcomes of fecal microbiota transplantation in patients with blood disorders, performed to eradicate gut colonization with multidrug-resistant (mdr) bacteria. patients with blood disorders are characterized by poor diversity of gut microbiome, affected by repeated chemotherapy and antimicrobial treatments. this makes them vulnerable to colonization by pathogenic bacteria carrying genes responsible for antibiotic resistance. in case of gut mucosa injury and severe immune suppression, these colonizing bacteria may cause severe systemic infections. as the bacteria are secreted with the stool, the colonized patients become an epidemiologic threat to the others. fecal microbiota transplantation (fmt) was shown to be very efficient in treatment of relapsed and refractory clostridium difficile infection and became a standard treatment. in home institution, the investigators use fmt not only in case of clostridium difficile colitis, but also in case of gut colonization with multidrug-resistant (mdr) bacteria. this is based on assumption that physiological gut flora may outcompete the pathogenic bacteria similarly as in case of clostridium difficile and lead to loss of colonization. the procedure is performed in all patients colonized, who qualify according to listed inclusion and exclusion criteria .


Eligibility criteria:
inclusion criteria: * age \>18 y * carrier status of mdr bacteria in stool: klebsiella pneumoniae resistant to carbapenems, pseudomonas aeruginosa resistant to carbapenems, enterococcus faecalis vre, enterococcus faecium vre, enterobacter cloacae kpc+ or other mdr species documented by at least two stool cultures * blood neutrophil count \> 500/ul on the day of fecal microbiota transplantation exclusion criteria: * inability to obtain informed consent and lack of consent * blood neutrophil count \<500/ul on the day of fecal microbiota transplantation or expected decrease to the mentioned number within 2 consecutive days * intensive, myelosuppressive chemotherapy (e.g. dhap, ice, eshap, hd-cy, hd-ara-c, da, conditioning before allogeneic stem cell transplantation, beacopp) planned within 2 consecutive days * patients up to 1 month after hematopoietic stem cell transplantation * clinical signs of mucositis * severe liver failure * patients undergoing intensive antimicrobial treatment

Keywords: fecal microbiota transplantation gut colonization multidrug-resistant bacteria blood disorders drug resistance, multiple disease eradication
music, virtual reality for patients in iugm

Conditions: Aging; Disorder, Neurologic

Summary: promoting good care, well-being and quality of life for geriatric patients is a long-standing initiative in quebec, and one in which the institut universitaire de gériatrie de montréal (iugm) has always been a leader. for example, the iugm played a major role in drafting the reference framework for the aapa (approach adapted to the needs of the elderly), which was introduced by the ministère de la santé et des services sociaux in 2011. the investigator propose to continue this work by focusing in this project on the development of a new intervention aimed at the well-being and quality of life of geriatric patients and based on music and vr. thee investigator hypothesize (1) that a vr headset-based intervention based on listening to and observing a concert of musicians playing classical music is feasible for patients hospitalized at the iugm's urfi and in patients attending the geriatric outpatient clinic, and (2) that this intervention can improve their mental health - i.e. their positive emotions, well-being and quality of life - and reduce their anxiety.


Eligibility criteria:
inclusion criteria: * be hospitalized at the urfi of the iugm, or being a patients attending the geriatric outpatient clinic * be 60 years of age or older, * not have an acute intercurrent pathology in the week preceding the procedure and during the two days of the procedure, * have no psycho-behavioural disorders, * no major neurocognitive disorder at a severe stage, * no severe visual or hearing impairment, * no vestibular balance disorders, * give written consent to participate in the study. exclusion criteria: * participate in another concurrent experimental clinical study, to avoid interference with our study. * do not understand written or spoken french or english. the participants are french and/or english speakers, and the questionnaires are only available in these 2 languages.
a clinical study to evaluate dnth103 in adults with multifocal motor neuropathy

Conditions: Multifocal Motor Neuropathy

Summary: the purpose of this phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of dnth103 in participants with multifocal motor neuropathy (mmn).


Eligibility criteria:
inclusion criteria: 1. must have given written informed consent before any study-related activities are carried out 2. adult males and females, 18 to 75 years of age (inclusive) 3. weight range between 40 to 120 kg 4. confirmed diagnosis of definite or probable mmn 5. evidence of: 1. responsiveness to ig treatment; and 2. receiving a stable ig regimen 6. documented vaccinations against encapsulated bacteria in accordance with local requirements and vaccine availability 7. female participants must be of nonchildbearing potential or if of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception 8. male participants must be surgically sterile for at least 90 days prior to screening or agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception exclusion criteria: 1. history or presence of significant medical/surgical condition including any acute illness or major surgery considered to be clinically significant or that could impact efficacy assessments 2. any coexisting conditions which may interfere with outcome assessments (eg, severe diabetic neuropathy) 3. concurrent or previous use of rituximab, cyclophosphamide, mycophenolate mofetil, azathioprine, or cyclosporine. if a participant has previously used these medications, the last dose must be at least 6 months prior to randomization 4. currently or previously on complement inhibitors including in a clinical trial setting 5. prior history (at any time) of n. meningitidis infection 6. diagnosis of an autoimmune disorder other than mmn 7. positive test results for active human immunodeficiency virus (hiv-1 or hiv-2), hepatitis b surface antigen (hbsag), or hepatitis c virus (hcv) antibodies during screening 8. history of active malignancy within 5 years prior to screening, except basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of the skin, cervical carcinoma in situ curatively treated or low-grade prostate adenocarcinoma for which appropriate management is observation alone 9. participation in another clinical study of an investigational drug within 90 days or 5 half-lives of the investigational agent (whichever is longer) prior to randomization (day 1) 10. any other overlapping condition for which the condition or treatment of the condition may affect the study assessments or outcomes 11. any other condition, including mental illness or prior therapy, that in the opinion of the investigator would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements